Cleared Traditional

K250608 - Mako Total Knee Application (3.0)

Also marketed or referenced as:
Hybrid Tip Pointer

K250608 is the FDA 510(k) clearance for Mako Total Knee Application (3.0) by Mako Surgical Corp.. It is a Class 2 Orthopedic device (product code OLO) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K250608 · Mako Surgical Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2025
Decision
56d
Days
Class 2
Risk

K250608 is an FDA 510(k) clearance for the Mako Total Knee Application (3.0). Classified as Orthopedic Stereotaxic Instrument within the OLO classification (a category covering orthopedic stereotaxic and surgical navigation instruments), Class II - Special Controls.

Submitted by Mako Surgical Corp. (Weston, US). The FDA issued a Cleared decision on April 25, 2025 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 882.4560 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Mako Surgical Corp. devices

Submission Details

510(k) Number K250608 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2025
Decision Date April 25, 2025
Days to Decision 56 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 122d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OLO Orthopedic Stereotaxic Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
Definition Stereotaxic Guidance During Orthopedic Surgery Procedures. Indicated For Orthopedic Joint Or Spine Surgery. Neurological Stereotaxic Instruments Are Classified Under Product Code Haw.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - OLO Orthopedic Stereotaxic Instrument

All 354
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K250608.
Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II
K251315 · Remex Medical Corp. · May 2025
OTS Hip
K250086 · Ortoma AB · May 2025
Altus Spine Navigation System
K243419 · Altus Partners, LLC · May 2025
Dynamis Robotic Surgical System
K243326 · LEM Surgical AG · Apr 2025
Medyssey Navigation System
K242806 · Medyssey Co, Ltd. · Apr 2025
Salvo® Robotic Navigation Instruments
K243514 · Spine Wave, Inc. · Apr 2025